UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Cathe
FDA device recall Z-2471-2012 · posted 2012-09-27 · Terminated
Recall details
- Recalling firm
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Reason for recall
- The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
- Action taken
- Micro Therapeutics Inc, Dba Ev3 Neurovascular sent a recall notification letter dated September 23, 2011 to all their affected customers. The letter identified the affected product, problem, and actions to be taken. The notification letter also provides the customer (physician) with appropriate information regarding the affected products. The letter instructs customer to stop using the affected product, segregate from inventory and return for replacement with conforming product. The notice requests the customer to complete and return the reply form indicating use or return of devices in the affected lot(s). Customers with questions regarding the recall letter were instructed to contact Kim Salceda at (949) 680-1305.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 36 units
- Distribution
- Worldwide Distribution - US Nationwide including the states: MN, FL, OR, TX and the countries of: Brazil, Belgium, Czech Republic, Finlind, France, Germany, Netherlands, Poland, and United Kingdom.
- Date initiated
- 2011-09-23
- Date posted
- 2012-09-27
- Date terminated
- 2012-09-28
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066 (K024118) | Micro Therapeutics, Inc. | 2003-02-03 |